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FDA 510(k) Application Details - K052030
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K052030
Device Name
Surgeon'S Gloves
Applicant
SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.
9 MOO 4 KACHED MUANG
RAYONG 21110 TH
Other 510(k) Applications for this Company
Contact
ANAN JETSADAWISUT
Other 510(k) Applications for this Contact
Regulation Number
878.4460
More FDA Info for this Regulation Number
Classification Product Code
KGO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/27/2005
Decision Date
09/13/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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